Device Use:

Reason for Recall:

Vascular Solutions is recalling the Guardian II Hemostasis Valve because of a defect in the low pressure seal, which may allow air bubbles into the device and block blood supply to the heart or blood vessels (air embolism).

The use of affected products may cause serious adverse health consequences, including death.

Who May be Affected:

Patient groups undergoing hemostasis therapy using this device

Health care professionals using this device for diagnostic or interventional catheterization procedures

What to Do:

On March 3, 2016, Vascular Solutions sent an Urgent: Medical Device Recall letter to customers asking them to:

identify the location of all affected products in their possession

remove and secure all affected products from their inventory

complete the inventory form enclosed with the letter and return it to Vascular Solutions’ customer service department by email at customerservice@vasc.com or by fax at 763-656-4251